510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160173Substantially Equivalent

Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)

Boston Scientific Corporation, Fremont CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160173 is the FDA 510(k) clearance record for Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU), a class II device, cleared for Boston Scientific Corporation on under FDA product code DXK (Echocardiograph). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K160173.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DXK Echocardiograph
Regulation
21 CFR 870.2330
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific Corporation 47215 Lakeview Blvd., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXK

Trailing 12 months

FDA records hold no clearances under product code DXK in the trailing twelve months.

FDA records show no clearances under product code DXK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DXK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260